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2024 ICH Guideline Reveals: Essential CMC and Drug Development Insights
Manage episode 449809218 series 3603634
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The podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)/Q14 for analytical validation, Q5(R2) for viral safety evaluation, and Q9(R1) for quality risk management. The text also examines the ICH's efforts to address emerging technologies in cell and gene therapy and real-world data utilization for safety assessments. Finally, the text discusses the impact of the ICH Biannual Assembly held in June 2024, including progress updates on current guidelines, the introduction of new proposals, and the harmonization of regulatory requirements across different regions.
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